Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-24 @ 9:56 PM
NCT ID:
NCT03179332
Eligibility Criteria:
Inclusion Criteria:
* Type 1 Diabetes Mellitus for more than 12 months.
* BMI between 18.5 and 28.5 kg/m².
* HbA1C level \<=9.0%.
* Insulin treated for at least 12 months with total insulin dose \<1.2U/kg/day.
Exclusion Criteria:
* Type 2 Diabetes Mellitus.
* History of multiple and/or severe allergies to drugs or foods.
* Any history or presence of clinically relevant cardiovascular, pulmonary, respiratory, gastrointestinal, hepatic, renal, metabolic, endocrinological (with the exception of conditions associated with diabetes mellitus), haematological, dermatological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynaecologic (if female), or infectious disease, or signs of acute illness as judged by the Investigator.
* More than one episode of severe hypoglycaemia with seizure, coma or requiring assistance of another person during the past 6 months.
* Proliferative retinopathy or maculopathy and/or severe neuropathy, in particular autonomic neuropathy.
* Females of childbearing potential, who are pregnant, breast-feeding or intend to become pregnant or are not using highly effective contraceptive methods.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT03179332
Study Brief:
Protocol Section:
NCT03179332